A Randomized, Sham Controlled Trial of Dorsal Root Rhizotomy Stereotactic Radiosurgery Versus Standard of Care for Spasticity Associated With Stroke, Spinal Cord Injury & Cerebral Palsy
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 22
- 试验地点
- 4
- 主要终点
- Change in Modified Ashworth Scale
研究概览
简要总结
A scientific study is being done to test a special treatment for people who have spasticity or tight muscles. This treatment is called "stereotactic radiosurgery dorsal rhizotomy." It uses very accurate beams of radiation to target certain nerves in the back to help loosen up the muscles. In this study, people are put into two groups by chance: one group gets the real treatment, and the other group gets a "fake" treatment that doesn't do anything. This fake treatment is called a "sham." Doing this helps make sure the study is fair and the results are true. After the people in the study get their treatment, the researchers will watch and see how they do. They will check if their muscles are less stiff and if they have any side effects. By looking at the results from both groups, the researchers can find out if the special treatment really helps people with spasticity. Patients who got the "fake" treatment will be eligible to receive the "real" treatment after 6 months.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Crossover
- 主要目的
- Treatment
- 盲法
- Double (Participant, Outcomes Assessor)
入排标准
- 年龄范围
- 16 Years 至 —(Child, Adult, Older Adult)
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Chronic spasticity refractory to medical management or in a patient who cannot receive appropriate medical management mediated by one or more spinal nerve roots
- •Age > 16 (if under 18, patients parents must sign consent).
排除标准
- •Inability to lie supine for simulation & treatment
- •Inability to visualize the target nerve on either CT or MRI imaging
- •Patients with confirmed pregnancy (all women of child-bearing age with intact uterus & ovaries will be required to undergo a pregnancy test prior to simulation)
结局指标
主要结局
Change in Modified Ashworth Scale
时间窗: 6 months post treatment
Change in the 6-month post-treatment Modified Ashworth Scale (MAS) measure of spasticity, which ranges from 0 (no symptoms) to 4 (worst symptoms)
次要结局
- Change in spasticity-related quality of life (SQoL-6D)(2 years post treatment)
研究者
Joshua Palmer
Professor, Radiation Oncology
Ohio State University
